Catheter for percutaneous transradial approach

ABSTRACT

An apparatus is guided by a guidewire within a luminal structure of a patient for receiving a radiation dose delivery wire with a radiation source attached to its distal end, for treating a disease process. The apparatus includes a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept a guidewire. The blind lumen is adapted to accept the radiation delivery wire into its proximal end. In a method of treating the disease process with the apparatus, the guidewire is inserted into the guidewire lumen of the balloon catheter, the balloon catheter is inserted into the patient&#39;s luminal structure at least as far as a predetermined section of the luminal structure, the radiation dose delivery wire is inserted into the blind lumen in the balloon catheter and moved a predetermined distance therein for a predetermined period of time, and, after the period has elapsed, the radiation dose delivery wire is removed from the blind lumen.

BACKGROUND OF THE INVENTION

[0001] This invention relates to preshaped tubular catheters forpercutaneous transradial approach to catheterization.

[0002] Preshaped catheters are commonly used for medical procedures suchas diagnosis or such as coronary angioplasty or coronary stentimplantation in which they serve to guide other catheters such aspressure measuring or balloon or stent loaded balloon catheters. Inthese procedures, a femoral approach is currently used in which thepreshaped catheter is introduced into the aorta via the femoral artery,and the catheter is then manipulated at its proximal end, by push orpull and/or torque motions, for steering its distal end into the lumenof the selected vessel. To assist in advancing the catheter through thecardiovascular system, a relatively stiff guidewire is inserted into thecatheter to straighten it out and bring the tip of the catheter in thedirection of origin of the selected artery prior to actual cannulation.After the catheter is inserted into the artery, the guidewire iswithdrawn, and the catheter may serve for a diagnosis procedure or forthe guidance of another catheter such as a balloon catheter or a stentloaded balloon catheter.

[0003] In order to properly achieve its guiding function, the preshapedcatheter should have an efficient backup or stability in the regionwhere it is placed in order to withstand the efforts and motions of thepulsating environment as well as the stresses and deformations caused bythe passage of the balloon catheter or other catheter or other equipmentwhich it guides. It should also assure a good coaxiality for properalignment with the ostium of the artery to avoid loss of push force onthe guided catheter or the risk of trauma caused by a stent loadedballoon catheter entering the vessel in a misaligned condition.Furthermore, the preshaped guiding catheter should have some automaticconfigurational adaptability to easily find its way through the vascularsystem with a minimal amount of manipulations to whenever possiblereduce the load of positioning travels for the patient. It should alsohave an appreciable capacity to deal with a variety of take-offs orangular positions which the left coronary artery, the right coronaryartery or venous by-pass grafts may have with respect to the aorticarch. And when in the selected position, the catheter should lock inplace and be releasable only under longitudinal tension from theoperator.

[0004] Accordingly, the preshaped guiding catheters should have aconfiguration of lines, curves and/or angles which precisely match theenvironmental context in which they will have to be used and it istherefore practically impossible to simply foresee the effects ofchanges made to the catheter shape.

[0005] A great number of preshaped catheters have been designed over theyears for the transfemoral catheterization.

[0006] For instance, the most commonly used catheter for left coronaryarteries, namely the catheter referred to as the “left Judkins” whichcomprises an elongated straight shaft portion followed by a distal endportion consisting of a straight portion extending from the shaftportion and followed by a curved portion for approximately 180° followedby a straight portion forming a small angle with the straight portionextending from the shaft portion, this last straight portion terminatingin a tip portion substantially perpendicular thereto. This catheter isoften made of a plastic material, and most of the catheters of that kindhave a flexibility which is unmodulated along their length. They arealso supplied in canted configurations to meet particular take-offrequirements. This kind of catheter cannot be applied to right coronaryarteries and, therefore, another catheter has been designed for rightcoronary arteries, namely the catheter referred to as the “rightJudkins”, also made of a plastic material, which comprises an elongatedshaft portion having the shape of an elongated S terminating in a tipportion substantially perpendicular to the distal end of the S shapedshaft portion. Most of the catheters of that kind also have aflexibility which is unmodulated along their length.

[0007] Other preshaped catheters made of a plastic material, most ofwhich have a flexibility which is unmodulated along their length havebeen designed, for example the catheters described in the document WO92/12 754 the purpose of which is to improve over the “Judkins”catheters. According to a first embodiment, intended for left coronaryarteries, the catheter comprises a first straight shaft portion followedby a distal end portion comprising a second straight portion extendingat an angle to the first straight portion, followed by a curved portionfor approximately 180° followed by a third straight portionsubstantially parallel to the second straight portion, and a tip portionextending from and at an angle from the third straight portion, this tipportion extending behind the first straight shaft portion; this catheteris adapted for use with a relatively stiff wire inserted therein. Asecond embodiment, also intended for left coronary arteries and for usewith a stiff wire inserted therein comprises an elongated first straightshaft portion followed by a distal end portion consisting of a secondstraight portion extending at an angle to the first straight shaftportion, a curved portion extending from the second straight portion forapproximately 180°, a third straight portion extending from the curvedportion at an angle to the second straight portion, and a tip portionextending at an angle to the third straight portion and parallel to thesecond straight portion, the tip portion extending behind the firststraight portion. A third embodiment, also intended for left coronaryarteries and use with a stiff guiding wire, and more particularly forleft coronary arteries which are angularly displaced posteriorly fromtheir normal distance (a situation referred to as posterior take-off),comprises a first straight portion extending from the proximal end ofthe catheter, and a distal end portion consisting of a second straightportion extending at an angle to the first straight portion and followedby a curved portion extending for approximately 180°, the curved portionbeing followed by a third portion terminating in a tip portion; in thiscatheter, the first and third straight portions are bent out of theplane formed by the second straight portion and the curved portion. Afourth embodiment intended for use with a stiff guidewire in a rightcoronary artery that is angularly displaced from its normal position andhas an anterior take-off, comprises a first straight portion and adistal end portion formed by a second straight portion extending fromthe first straight portion at an angle in a first plane which is between50° and 70° and at an angle in a second plane which is perpendicular tothe first plane which is between 20° and 40°; a third straight tipportion extends from the second straight portion at an angle which isbetween 20° and 30° in the first plane and at an angle between 40° and50° to the second straight portion. A fifth embodiment, intended for usewith a stiff guidewire in a venous by-pass connecting the aorta to thedistal segment of the right coronary artery, comprises a first straightshaft portion and a distal end portion consisting of a first curvedportion extending the first straight portion, a second curved portionextending the first curved portion oppositely thereto and followed by astraight tip portion parallel to the first straight portion.

[0008] Still other preshaped catheters are available on the market suchas, for instance, the catheter referred to as the “left Amplatz” or the“right Amplatz” which is constructed on variations of a basic shapehaving a straight elongated shaft followed by a first curve in a firstdirection followed by a second curve in the opposite direction, or thecatheter referred to as the “Multipurpose” which bases on a shape havinga substantially straight shaft portion followed by a curve, most ofwhich have a flexibility which is unmodulated along their length.

[0009] A percutaneous transradial approach to catheterization is nowbeing investigated because of favorable anatomical relations of theradial artery to its surrounding structures and the double blood supplyto the hand. Potential benefits of this approach are safe transarterialcoronary interventions combining rapid mobilization of the patient afterintervention, with the resulting reduced hospitalization, and easy,safe, and effective hemostasis leading to a marked reduced incidence ofaccess-site related major complications.

[0010] So far, there are, however, no specific catheters available forthis technique. Typically, catheters such as those referred tohereinabove, which are specific to percutaneous transfemoralcatheterization approach, have been used, however with relative lack ofsuccess on backup and coaxiality in alignment with the artery.Furthermore, they usually require a straightening wire for bringing thetip of the catheter in the direction of the ostium of the artery. And aplurality of catheters is needed to meet the various take-offconfigurations; and even so, they need some tricks to be properly used.

[0011] It is therefore an object of the present invention to improve thepercutaneous transradial approach to catheterization by proposing acatheter specific to transradial catheterization. It is a further objectof the invention to provide a catheter for transradial approach whichavoids the drawbacks of the catheters for femoral approach used fortransradial approach. Still a further object of the invention is toprovide a catheter for transradial approach which is simple tomanufacture with available techniques, and which avoids unnecessarycosts as well as complex stock supply or ordering procedures.

SUMMARY OF THE INVENTION

[0012] Accordingly, the combination of a flexible primary curve withstiff structures provides modulated flexibility and allows selectivecannulation of right coronary arteries, left coronary arteries, andvenous by-pass grafts. It also permits dealing with a variety oftake-off conditions of the right coronary artery, the left coronaryartery and venous by-pass grafts. As it permits to bring the tip of thecatheter in the direction of the origin of the coronary artery, prior toany cannulation, there is an improved coaxiality of the catheter. Deepintubation across sharp curves of coronary irregularities is alsopossible. The stiff structures assure support on contralateral aorticsinus and extra support against aortic wall; they optimize the torqueand kink resistance during catheter manipulations; they also optimizethe support for easier manipulation and change of angles of the primarycurve; and once the catheter is positioned they assure full backup tothe catheter.

[0013] As a result, there is no need for a guidewire to bring the tip ofthe catheter in the direction of the origin of the coronary, prior tocannulation. There is a smooth passage of stents by reduced friction atthe site of the catheter curves. The success of stent delivery is thusgreatly improved and stent implantation may become a current procedure,not only for elective cases, and without the need to exchange guidingcatheters.

[0014] A further advantage is that the catheter has a multipurposecapacity for dealing with right coronary arteries, left coronaryarteries, and venous by-pass grafts, without the necessity to exchangecatheters during a multivessel procedure, thereby preventing arteryspasm and discomfort, potential loss of distal access in case of extremetortuosity, long procedural and fluoro time, as well as unnecessarycosts and heavy stock procedures.

[0015] And of course the catheter has compatibility for percutaneoustransluminal coronary angioplasty, perfusion, stent delivery anddiagnostic.

[0016] In sum, the present invention relates to a preshaped tubularcatheter for percutaneous transradial approach to catheterization,having a distal bridge shaped portion having a distal arch defining aprimary curve, a top defining a secondary curve, and a proximal archdefining a tertiary curve. The proximal arch is connected to a distalend of a straight and stiff shaft, and the bridge shaped portion has aflexibility extending at least up to and including the primary curve anda stiffness extending at least up to and including the tertiary curve.The distal bridge shaped portion may have a first distal straightportion, a primary curve extending from the first distal straightportion, the primary curve having a concavity oriented towards aproximal end of the bridge shaped portion, a second straight portionextending from the primary curve, the second straight portion beinginclined towards the proximal end of the bridge shaped portion, asecondary curve extending from the second straight portion, thesecondary curve having a concavity oriented between the first distalstraight portion and the proximal end of the bridge shaped portion, athird straight portion extending from the secondary curve, the thirdstraight portion being inclined towards the proximal end of the bridgeshaped portion, and a tertiary curve extending from the third straightportion, the tertiary curve having a concavity oriented towards thefirst distal straight portion, and the tertiary curve having a proximalend connected to the distal end of the straight shaft. The flexibilityof the bridge shaped portion may extend at least over the first distalstraight portion, the primary curve, and a distal portion of the secondstraight portion. The secondary curve may extend over about 90°, and thetertiary curve may extend over about 45°. The second straight portionand the third straight portion may be essentially the same length. Thefirst distal straight portion may be substantially parallel to thestraight shaft.

[0017] The above and other objects, features and advantages of theinvention will become readily apparent from the following detaileddescription with reference to the accompanying drawings which show,diagrammatically and by way of example only, a preferred but stillillustrative embodiment of the invention.

DESCRIPTION OF THE DRAWINGS

[0018]FIGS. 1 and 2 are side and front views, respectively of a portionof the catheter according to the invention.

[0019]FIGS. 3, 4 and 5 are, respectively, cross sectional views of aportion of a cardiovascular system with the catheter inserted in theleft coronary artery.

[0020]FIG. 6 is a cross sectional view of a portion of a cardiovascularsystem with the catheter inserted in the right coronary artery.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0021] The catheter shown in FIGS. 1 and 2 is tubular and comprises adistal bridge shaped portion 1 having a distal arch 2 defining a primarycurve 3, a top 4 defining a secondary curve 5, and a proximal arch 6defining a tertiary curve 7. The proximal arch 6 is connected to adistal end 8 of a straight shaft 9 the proximal end of which is fittedwith the usual handling connector (not shown). The shaft 9 is stiff andthe bridge shaped portion 1 has a flexibility extending at least up toand including the primary curve 3 and a stiffness extending at least upto and including the tertiary curve 7.

[0022] More specifically, the bridge shaped portion 1 comprises a firstdistal straight portion 10, a first primary curve 3 extending from saidfirst straight portion 10, which primary curve has a concavity orientedtowards the proximal end 11 of the bridge shaped portion 1. A secondstraight portion 12 extends from primary curve 3 and is inclined towardsthe proximal end 11 of the bridge shaped portion 1. A secondary curve 5extends from the second straight portion 12 and said secondary curve hasa concavity oriented between the first distal straight portion 10 andthe proximal end 11 of bridge shaped portion 1. A third straight portion13 extends from the secondary curve 5, and said straight portion 13 isinclined towards the proximal end 11 of bridge shaped portion 1. Atertiary curve 7 extends from third straight portion 13, and saidtertiary curve has a concavity oriented towards the first distalstraight portion 10; a proximal end 14 of said tertiary curve isconnected to the distal end 8 of the shaft 9.

[0023] The shaft 9 is stiff and, preferably, the flexibility of thebridge shaped portion 1 extends over the first distal straight portion10, the primary curve 3 and a distal portion 15 of second straightportion 12 while the proximal part of second straight portion 12, thesecondary curve 5, the third straight portion 13 and the tertiary curve7 are stiff. Stiffness may be obtained, for example, by a braiding 16embedded in the plastic material forming the catheter or otherwise, forexample, by quality of the material at the appropriate regions.

[0024] Preferably, the secondary curve extends over about 90° and thetertiary curve extends over about 45°. However, these data may beselected otherwise.

[0025] In a preferred embodiment, the second straight portion 12 and thethird straight portion 13 are essentially of the same length. Anotherchoice is however possible, for instance the second and third straightportions may have a differing length.

[0026] The first distal straight portion 10 may be, as shown,substantially parallel to the straight shaft 9. However, this firstdistal straight portion 10 may be selected at an angle opening in thedirection of straight shaft 9.

[0027] Instead of extending up to the distal portion 15 of secondstraight portion 12, the flexibility of the bridge shaped portion 1 mayextend closer to the primary curve 3 or proximally beyond the distalportion 15 of second straight portion 12.

[0028] The distal end of first distal straight portion 10 may be fittedwith a soft tip to be fully atraumatic.

[0029]FIG. 3 shows a cardiovascular system 17 in which the left coronaryartery 18 has a horizontal take-off. As may be seen, the tertiary curve7 rests on the aortic wall; upon pulling the catheter, the secondarycurve 5 will deflect the primary curve 3 so that the first straightportion 10 coaxially engages the ostium of the artery.

[0030]FIG. 4 shows a cardiovascular system 19 in which the left coronaryartery 20 has a downward take-off. In this situation a pull on thecatheter will modify the support conditions of secondary and tertiarycurves 5 and 7 to re-direct primary curve 3 and first straight portion10 in the direction of the ostium of the artery.

[0031]FIG. 5 shows a cardiovascular system 21 in which the left coronaryartery has a vertical take-off. In such a condition, the catheter willneed a push so that the tertiary curve 7 lies deeper in the root wherebythe secondary curve 5 will divert the primary curve 3 to have it take amore vertical position to secure coaxiality of the first straightportion 10 with the ostium of the artery.

[0032]FIG. 6 shows a cardiovascular system 23 in which the rightcoronary artery is shown in a horizontal take-off 24, respectively inupward take-off 24′, respectively in a downward take-off 24″. As may beseen, the tertiary curve 7 and secondary curve 5 assure a correctdirectioning of primary curve 3 and first straight portion 10 in coaxialalignment with the artery. To achieve engagement into the upwardtake-off 24′, a push on the shaft 9 of the catheter will give an upwarddeflection of primary curve 3 and the corresponding upward directioningof first straight portion 10 to coaxially engage the artery. Engagementinto the downward take-off 24″ will require a pull on shaft 9 of thecatheter so that the primary curve 3 will take a more downwarddeflection which will re-direct downwardly the first straight portion 10to properly engage the ostium coaxially.

[0033] As may be seen, in all these conditions, the catheter has astrong back-up due to the supporting condition of the tertiary curve,and/or secondary curve, and/or third straight portion.

1. A preshaped tubular catheter for percutaneous transradial approach tocatheterization, comprising a distal bridge shaped portion having adistal arch defining a primary curve, a top defining a secondary curve,and a proximal arch defining a tertiary curve, wherein said proximalarch is connected to a distal end of a straight and stiff shaft, andwherein said bridge shaped portion has a flexibility extending at leastup to and including the primary curve and a stiffness extending at leastup to and including said tertiary curve.
 2. A catheter according toclaim 1, wherein the distal bridge shaped portion comprises a firstdistal straight portion, a primary curve extending from said firstdistal straight portion, said primary curve having a concavity orientedtowards a proximal end of said bridge shaped portion, a second straightportion extending from said primary curve, said second straight portionbeing inclined towards said proximal end of the bridge shaped portion, asecondary curve extending from said second straight portion, saidsecondary curve having a concavity oriented between said first distalstraight portion and said proximal end of said bridge shaped portion, athird straight portion extending from said secondary curve, said thirdstraight portion being inclined towards the proximal end of said bridgeshaped portion, and a tertiary curve extending from said third straightportion, said tertiary curve having a concavity oriented towards saidfirst distal straight portion, and said tertiary curve having a proximalend connected to said distal end of said straight shaft.
 3. A catheteraccording to claim 2, wherein said flexibility of the bridge shapedportion extends at least over said first distal straight portion, saidprimary curve, and a distal portion of said second straight portion. 4.A catheter according to claim 2, wherein said secondary curve extendsover about 90°.
 5. A catheter according to claim 2, wherein saidtertiary curve extends over about 45°.
 6. A catheter according to claim2, wherein said second straight portion and said third straight portionare of essentially the same length.
 7. A catheter according to claim 2,wherein said first distal straight portion is substantially parallel tosaid straight shaft.